Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122021507 | 12202150 | 7 | F | 20160311 | 20160902 | 20160323 | 20160909 | EXP | CA-ROCHE-1728407 | ROCHE | 30.95 | YR | F | Y | 0.00000 | 20160909 | MD | CA | CA |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122021507 | 12202150 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0002F,S0068D | 103976 | 150 | MG | SOLUTION FOR INJECTION | ||||||
| 122021507 | 12202150 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0062,S0002F,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 122021507 | 12202150 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0062,S0002F,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 122021507 | 12202150 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0062,S0002F,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 122021507 | 12202150 | 5 | C | REACTINE (CANADA) | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | U | 0 | 20 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122021507 | 12202150 | 1 | Chronic spontaneous urticaria |
| 122021507 | 12202150 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122021507 | 12202150 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122021507 | 12202150 | Anaphylactic reaction | |
| 122021507 | 12202150 | Drug ineffective | |
| 122021507 | 12202150 | Herpes zoster | |
| 122021507 | 12202150 | Lower respiratory tract congestion | |
| 122021507 | 12202150 | Lower respiratory tract infection | |
| 122021507 | 12202150 | Malaise | |
| 122021507 | 12202150 | Nasopharyngitis | |
| 122021507 | 12202150 | Oropharyngeal pain | |
| 122021507 | 12202150 | Pneumonia | |
| 122021507 | 12202150 | Productive cough | |
| 122021507 | 12202150 | Pruritus | |
| 122021507 | 12202150 | Pyrexia | |
| 122021507 | 12202150 | Sinusitis | |
| 122021507 | 12202150 | Urticaria |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 122021507 | 12202150 | 1 | 20160311 | 0 | ||
| 122021507 | 12202150 | 2 | 20160630 | 0 | ||
| 122021507 | 12202150 | 3 | 20160729 | 0 | ||
| 122021507 | 12202150 | 4 | 20160825 | 0 |